Critical Limb IschemiaPhase 3NCT01245335
Bone Marrow Aspirate Concentrate (BMAC) for Treatment of Critical Limb Ischemia (CLI)
A Phase 3 study testing BMAC injection in people with Critical Limb Ischemia, run by Harvest Technologies at 34 sites in United States.
Trial summary
Critical Limb Ischemia prevents the legs and feet from receiving oxygen and nutrients needed for proper function. This severe lack of blood flow can lead to painful legs while walking or at rest and can result in foot sores, ulcers, gangrene, and even amputation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Limb Ischemia
- What is being tested?
- BMAC injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 34 sitesUnited States
- Study dates
- May 2011to Nov 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has Peripheral Arterial Occlusive Disease (PAOD) with clinical Rutherford Category 5 disease, as defined in the reporting standards adopted by the Society of Vascular Surgeons(table 1); Minor Tissue loss-focal gangrene with diffuse pedal ischemia
- Patient meets at least one of the following diagnostic criteria in the study limb:
- Ankle artery occlusion pressure absolute ≤60 mmHg or ABI ≤0.6
- Toe artery occlusive pressure < 50mm Hg or TBI ≤0.6
- There is no reasonable open surgical or endovascular revascularization option as determined by the treating vascular specialist. Factors that may contribute to the determination of inoperability may include:
- Anatomical considerations
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- No outflow targets
- No appropriate conduit (i.e. vein for bypass)
- Long segment occlusions or calcified lesions that predict poor outcome with endovascular approaches.
- High risk medical conditions i.e. Unstable cardiac disease.
- History of prior failed revascularization attempts
- The Patient's case was reviewed at the treating institution's Multidisciplinary Vascular Conference where the patient's status as a poor candidate for conventional therapies was confirmed.
- Age ≥18 years and ability to understand the planned treatment
- Subject has read and signed the IRB approved Informed Consent form
- Patients for whom the following medication(s) is prescribed must have a one month stable baseline therapy prior to enrollment: Plavix/asprin therapy, anticoagulation therapy, cholesterol lowering agent, and or blood pressure medication. If any of these medications are not prescribed notation of the reason for omission is to be provided.
- Hematocrit ≥ 28.0%, White Blood Cell count ≤ 14,000, Platelet count ≥ 50,000, Creatinine ≤ 2.5 mg / dL, INR ≤ 1.6 unless on Coumadin, or PTT <1.5 x control (to avoid bleeding complications) Patients on Coumadin will be corrected prior to the procedure and must have an INR<1.6 at the time of randomization/surgery.
Who cannot join
- Life expectancy <6 months due to concomitant illnesses
- History of bone marrow diseases (especially NHL, MDS) that prohibit transplantation
- Terminal renal failure with existing dependence on dialysis or serum creatinine >2.5 mg/dL
- Known active malignancy or results outside of normal limits from the following tests: PAP, Chest X-ray, PSA, Mammogram, Hemocult unless follow-up studies reveal patient to be cancer free.
- Poorly controlled diabetes mellitus (HgbA1C>10%)
- Medical risk that precludes anesthesia (conscious sedation), or ASA Class 5
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- Life-threatening complications of the ischemia necessitating immediate amputation
- Uncorrected occlusion of the common or external iliac artery on index side
- Absence of any pulsatile Doppler flow below the ankle.
- Extensive necrosis of the index limb or other conditions that make amputation inevitable (Rutherford Category 6).
- Ulceration with exposed bone proximal to the distal metatarsal heads (ie. heel or mid foot)
- Active clinical infection or infection being treated by antibiotics within one week of enrollment
- Treatment with immunosuppressant drugs (including Prednisone > 5 mg per day).
- Female who is pregnant or nursing, or of child bearing potential and is not using a reliable birth control method.
- Underwent a major open cardiovascular surgical procedure (carotid endarterectomy, arterial aneurysm or bypass surgery, or coronary artery bypass surgery) or a myocardial infarction within the 3 months prior to randomization
- Underwent a successful or partially successful endovascular intervention for peripheral arterial occlusive disease. (ie. Aorta, iliac, femoral, popliteal, or tibial artery angioplasty, stenting, or atherectomy) within the prior 3 months.
- Endovascular coronary intervention (ie. Angioplasty, atherectomy, stenting) within 1 month prior to randomization.
- Underwent a failed attempt for endovascular revascularization during the prior 1 month. For the purpose of this exclusion criteria an endovascular procedure is considered a failure if:
- The procedure is diagnostic only with no intervention performed, (for example in the case where wire crossing can not be obtained).
- The treated artery recoils, thromboses, or dissects resulting in occlusion of the treated arterial segment, documented by intraoperative imaging. Note that endovascular procedures with suboptimal results but not meeting criteria 1 or 2 above may qualify for inclusion after 3 months as in #16 above.
- Cerebrovascular accident within 6 months prior to randomization.
- Treatment with topical growth factors or hyperbaric oxygen (HBO) within 30 days, or systemic growth factor treatment within 6 months of enrollment.
- Known hypersensitivity to heparin; or history of heparin-induced thrombocytopenia (HIT).
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
United States34 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21287
University of Alabama
Birmingham, Alabama, 35294-0012
Tufts Medical Center
Boston, Massachusetts, 02111
Beth Israel Deaconess
Boston, Massachusetts, 02215
Cooper University Hospital
Camden, New Jersey, 08103
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Roper St Francis Medical Center
Charleston, South Carolina, 29401
Charleston Area Medical Center Institute
Charleston, West Virginia, 25304
University of Illinois-Chicago
Chicago, Illinois, 60612
University of Cincinnati
Cincinnati, Ohio, 45267
Baylor Medical Ctr
Dallas, Texas, 75226
Medical Center of South Arkansas
El Dorado, Arkansas, 71730
Greenville Health System
Greenville, South Carolina, 29615
University of Texas - Houston Medical School
Houston, Texas, 77030
Kansas City Vascular
Kansas City, Missouri, 64116
University of Tennessee
Knoxville, Tennessee, 37920
North Shore-Long Island Jewish
Lake Success, New York, 11042
Dartmouth Hitchcock Medical Ctr
Lebanon, New Hampshire, 03756
Regional Infectious Disease and Infusion Ctr
Lima, Ohio, 45801
USC Keck School of Medicine
Los Angeles, California, 90033
Ochsner Clinic
New Orleans, Louisiana, 70121
St. Luke's Roosevelt
New York, New York, 10025
Florida Hospital - Vascular Institute of Central Florida
Orlando, Florida, 32804
Coastal Vascular & Interventional
Pensacola, Florida, 32503
Maine Medical Ctr
Portland, Maine, 04102
Oregon Health Science University
Portland, Oregon, 97239
Rhode Island Hospital
Providence, Rhode Island, 02903
Mercy Hospital
St Louis, Missouri, 63141
USF / Tampa General
Tampa, Florida, 33606
Holy Name Medical Center
Teaneck, New Jersey, 07666
University of Oklahoma
Tulsa, Oklahoma, 74135
Peace Health Southwest Medical Center
Vancouver, Washington, 98682
Cadence Health, Central DuPage Hospital
Winfield, Illinois, 60190
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
Official title: Pivotal Study of the Safety and Effectiveness of Autologous Bone Marrow Aspirate Concentrate (BMAC) for the Treatment of Critical Limb Ischemia Due to Peripheral Arterial Disease
Critical Limb Ischemia prevents the legs and feet from receiving oxygen and nutrients needed for proper function. This severe lack of blood flow can lead to painful legs while walking or at rest and can result in foot sores, ulcers, gangrene, and even amputation. The purpose of this study is to determine if injections of concentrated bone marrow into damaged tissues will result in improved blood flow. If successful, this treatment could improve blood flow to the lower limb, reduce pain, and reduce the frequency of limb amputations.
Read the detailed description
Bone marrow aspirate is collected and processed by centrifugation to remove red blood cells. The resulting concentrate of cells is injected into ischemic tissues of the lower limb. The purpose of this study is to determine if injections of concentrated bone marrow nucleated cells into ischemic tissues will result in vasculogenesis.
- Conditions
- Critical Limb Ischemia
- Being tested
- BMAC injection, Placebo injection
- Keywords
- CLI, Critical Limb Ischemia, PAOD, Peripheral Arterial Disease, Stem Cells, Limb amputation, Leg ulcers
- Medical subject headings
- Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease, Leg Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMAC injectionDevice
Injection of 40 ml of autologous bone marrow aspirate concentrate (BMAC injection) prepared with the SmartPReP2 BMAC System
Placebo injectionDevice
Injection of placebo into ischemic tissue of the lower extremity
| Study group | Role | What they receive |
|---|---|---|
| BMAC Treatment | Active comparator | Intervention- Injection of 40 ml of autologous bone marrow concentrate (BMAC injection) prepared with the SmartPReP2 BMAC System Receives: Device: BMAC injection |
| Placebo Injection | Placebo comparator | Injection of placebo (diluted peripheral blood) into ischemic tissue of the lower extremity Receives: Device: Placebo injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amputation Free Survival
Survival without a major (above the ankle) amputation
Measured: Six Months
Secondary outcomes (2)
Change In Rutherford Classification
Change in the subjects clinical status as measured by Rutherford Classification
Measured: Six Months
Change in Pain
Change in Subjects perception of pain as measured on a 100 mm visual analog scale
Measured: Six Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2010 (estimated)
- Study startMay 2011
- Primary completionAug 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Limb IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvest Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Iafrati, MD, Principal investigator, Tufts Medical Ctr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01245335
- Sponsor's protocol ID
- CLI-2011-1
- Status last verified
- Dec 2015
- First submitted
- 18 Nov 2010
- Last updated
- 15 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivotal Study of the Safety and Effectiveness of Autologous Bone Marrow Aspirate Concentrate (BMAC) for the Treatment of Critical Limb Ischemia Due to Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT01245335
- Acronym / sponsor ID
- CLI-2011-1
- Conditions
- Critical Limb Ischemia
- Keywords
- CLI, Critical Limb Ischemia, PAOD, Peripheral Arterial Disease, Stem Cells, Limb amputation, Leg ulcers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Harvest TechnologiesIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Aug 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 22 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Critical Limb Ischemia prevents the legs and feet from receiving oxygen and nutrients needed for proper function. This severe lack of blood flow can lead to painful legs while walking or at rest and can result in foot sores, ulcers, gangrene, and even amputation. The purpose of this study is to determine if injections of concentrated bone marrow into damaged tissues will result in improved blood flow. If successful, this treatment could improve blood flow to the lower limb, reduce pain, and reduce the frequency of limb amputations.
Detailed description
Bone marrow aspirate is collected and processed by centrifugation to remove red blood cells. The resulting concentrate of cells is injected into ischemic tissues of the lower limb. The purpose of this study is to determine if injections of concentrated bone marrow nucleated cells into ischemic tissues will result in vasculogenesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BMAC Treatment | Active comparator | Device: BMAC injectionIntervention- Injection of 40 ml of autologous bone marrow concentrate (BMAC injection) prepared with the SmartPReP2 BMAC System |
| Placebo Injection | Placebo comparator | Device: Placebo injectionInjection of placebo (diluted peripheral blood) into ischemic tissue of the lower extremity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patient has Peripheral Arterial Occlusive Disease (PAOD) with clinical Rutherford Category 5 disease, as defined in the reporting standards adopted by the Society of Vascular Surgeons(table 1); Minor Tissue loss-focal gangrene with diffuse pedal ischemia
- Patient meets at least one of the following diagnostic criteria in the study limb:
- There is no reasonable open surgical or endovascular revascularization option as determined by the treating vascular specialist. Factors that may contribute to the determination of inoperability may include:
- No outflow targets
- No appropriate conduit (i.e. vein for bypass)
Key exclusion criteria (23 listed)
- Life expectancy <6 months due to concomitant illnesses
- History of bone marrow diseases (especially NHL, MDS) that prohibit transplantation
- Terminal renal failure with existing dependence on dialysis or serum creatinine >2.5 mg/dL
- Known active malignancy or results outside of normal limits from the following tests: PAP, Chest X-ray, PSA, Mammogram, Hemocult unless follow-up studies reveal patient to be cancer free.
- Poorly controlled diabetes mellitus (HgbA1C>10%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMAC injectionInjection of 40 ml of autologous bone marrow aspirate concentrate (BMAC injection) prepared with the SmartPReP2 BMAC System | Device | BMAC Treatment |
| Placebo injectionInjection of placebo into ischemic tissue of the lower extremity | Device | Placebo Injection |
Primary outcome
Amputation Free Survival
Time frame: Six Months
Survival without a major (above the ankle) amputation
2 secondary outcomes
Change In Rutherford Classification
Time frame: Six Months
Change in Pain
Time frame: Six Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Iafrati, MD principal investigator
Tufts Medical Ctr
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BMAC injection in people with Critical Limb Ischemia, run by Harvest Technologies at 34 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amputation Free Survival (time frame: Six Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2015; AzTrials last refreshed its copy on 7 Nov 2026.